Pseudoephedrine Espefa

Package Leaflet: Information for the Patient

PSEUDOEPHEDRINE ESPEFA, 60 mg, Coated Tablets

Pseudoephedrine Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is PSEUDOEPHEDRINE ESPEFA and what is it used for
• 2. Important information before taking PSEUDOEPHEDRINE ESPEFA
• 3. How to take PSEUDOEPHEDRINE ESPEFA
• 4. Possible side effects
• 5. How to store PSEUDOEPHEDRINE ESPEFA
• 6. Contents of the pack and other information

1. What is PSEUDOEPHEDRINE ESPEFA and what is it used for

PSEUDOEPHEDRINE ESPEFA reduces the swelling of the mucous membrane of the upper respiratory tract, especially the nasal mucosa and paranasal sinuses, leading to a reduction in swelling and discharge and clearance of the nose.
PSEUDOEPHEDRINE ESPEFA is used for symptomatic treatment of inflammation of the nasal mucosa and paranasal sinuses (cold, runny nose) in the course of:

• common cold,
• flu,
• allergic rhinitis.

The medicine is intended for adults and adolescents over 12 years of age.
If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking PSEUDOEPHEDRINE ESPEFA

When not to take PSEUDOEPHEDRINE ESPEFA:

• if the patient is allergic to pseudoephedrine or any of the other ingredients of this medicine (listed in section 6).
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension.
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or kidney failure.
• if the patient has severe coronary artery disease.
• if the patient is taking or has taken within the last two weeks monoamine oxidase inhibitors (drugs used, among others, in depression). Concomitant use of PSEUDOEPHEDRINE ESPEFA with such drugs may sometimes lead to increased blood pressure or hypertensive crisis.
• if the patient is taking furazolidone. The antibacterial furazolidone has dose-dependent monoamine oxidase inhibiting activity. Despite the lack of reports of hypertensive crisis caused by concomitant use of PSEUDOEPHEDRINE ESPEFA and furazolidone, these drugs should not be used concomitantly.

Warnings and precautions

Before starting treatment with PSEUDOEPHEDRINE ESPEFA, the patient should discuss it with their doctor:

• if the patient has hypertension, heart disease,
• if the patient has diabetes, hyperthyroidism, increased intraocular pressure, or prostate enlargement,
• if the patient has liver or kidney function disorders.

The patient should stop taking PSEUDOEPHEDRINE ESPEFA and immediately consult a doctor or seek medical attention if they experience:

• sudden abdominal pain, rectal bleeding, or other symptoms of developing colitis,
• fever with generalized skin redness and pustular rash (see section 4).

After taking pseudoephedrine-containing medications, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported.
PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain.
If symptoms occur that may be symptoms of PRES or RCVS, the patient should immediately stop taking PSEUDOEPHEDRINE ESPEFA and seek medical attention immediately (symptoms, see section 4 "Possible side effects").
If after 3 days the symptoms do not resolve, worsen, or new symptoms appear, the patient should stop taking the medicine and consult a doctor.

PSEUDOEPHEDRINE ESPEFA with alcohol

The patient should avoid concomitant use of PSEUDOEPHEDRINE ESPEFA and alcohol.

Children and adolescents

PSEUDOEPHEDRINE ESPEFA should not be used in children under 12 years of age.

PSEUDOEPHEDRINE ESPEFA and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
PSEUDOEPHEDRINE ESPEFA should not be used with the following medicines:

• monoamine oxidase inhibitors (drugs used, among others, in depression). Concomitant use of PSEUDOEPHEDRINE ESPEFA with such drugs may sometimes lead to increased blood pressure or hypertensive crisis.
• furazolidone (an antibacterial drug), which has dose-dependent monoamine oxidase inhibiting activity.

Before taking PSEUDOEPHEDRINE ESPEFA, the patient should consult a doctor if they are taking:

• tricyclic antidepressants,
• drugs that reduce nasal congestion,
• appetite suppressants,
• psychotropic drugs with amphetamine-like effects,
• blood pressure lowering drugs, such as bretylium, betanidine, guanethidine, debrisoquine, methyldopa, and alpha- and beta-adrenergic receptor blockers. PSEUDOEPHEDRINE ESPEFA may weaken the effect of these drugs.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
PSEUDOEPHEDRINE ESPEFA may be used during pregnancy and breastfeeding only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus or breastfed child.

Driving and using machines

It is not known whether the medicine affects the ability to drive or use machines.

PSEUDOEPHEDRINE ESPEFA contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

PSEUDOEPHEDRINE ESPEFA contains Allura Red AC (E 129)

The medicine may cause allergic reactions.

3. How to take PSEUDOEPHEDRINE ESPEFA

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult a doctor or pharmacist.
The medicine is taken orally.

Dosage for adults and adolescents over 12 years of age

One coated tablet 3 to 4 times a day, in adolescents for a maximum of 4 days.

Dosage for elderly patients

No specific studies have been conducted on the use of PSEUDOEPHEDRINE ESPEFA in elderly patients. It is recommended to use the same dosage as for adults and to pay special attention to kidney and liver function. If there is severe impairment of these organs, the medicine should be used with caution.

Dosage for patients with liver failure

Caution should be exercised when using the medicine in patients with severe liver function disorders.

Dosage for patients with kidney failure

Caution should be exercised when using the medicine in patients with moderate or severe kidney function disorders.

Taking a higher dose of PSEUDOEPHEDRINE ESPEFA than recommended

Symptoms of overdose are: nausea, vomiting, insomnia, tremors, dilated pupils, anxiety, agitation, hallucinations, seizures, palpitations, tachycardia, reflex bradycardia, arrhythmias, hypertensive crisis, intracranial hemorrhage, myocardial infarction, psychosis, muscle damage, low potassium levels in the blood, and intestinal ischemia. In cases of overdose in children, drowsiness has been reported.

Procedure in case of overdose

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist. The doctor will take appropriate actions, such as supporting breathing and administering anticonvulsant drugs if necessary. In justified cases, gastric lavage may be performed. It may be necessary to catheterize the bladder. If the doctor deems it appropriate, the elimination of pseudoephedrine can be accelerated by administering urine acidifying drugs or subjecting the patient to dialysis.

Missing a dose of PSEUDOEPHEDRINE ESPEFA

The patient should not take a double dose to make up for a missed dose.
If the patient has any further doubts about the use of this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, PSEUDOEPHEDRINE ESPEFA can cause side effects, although not everybody gets them.
Frequent side effects (less than 1 in 10 people):

• dry mouth, nausea,
• dizziness,
• insomnia, nervousness.

Very rare side effects (less than 1 in 10,000 people):

• arrhythmias, myocardial infarction, palpitations, tachycardia,
• allergic reactions,
• rash, itching, sudden onset of limited skin and (or) mucous membrane edema, which can cause difficulty breathing or swallowing,
• increased blood pressure,
• stroke, headache, paresthesia, excessive psychomotor activity, tremors, drowsiness,
• anxiety, euphoria, hallucinations, visual hallucinations, restlessness,
• ischemic colitis (see section Warnings and precautions), vomiting,
• painful urination, urinary retention. Side effects with unknown frequency (frequency cannot be estimated from available data):
• severe vascular disorders affecting the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

The patient should immediately stop taking PSEUDOEPHEDRINE ESPEFA and seek medical attention if they experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures,
• vision changes.
• sudden fever, skin redness, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP), which may occur within the first 2 days of taking the medicine. See section 2. If such symptoms occur, the patient should stop taking the medicine and consult a doctor or seek medical attention immediately.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store PSEUDOEPHEDRINE ESPEFA

The medicine should be stored at a temperature below 25°C.
Store in the original packaging to protect from moisture.
The medicine should be stored out of sight and reach of children.
Do not use PSEUDOEPHEDRINE ESPEFA after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What PSEUDOEPHEDRINE ESPEFA contains

• The active substance of the medicine is pseudoephedrine hydrochloride. One coated tablet contains 60 mg of pseudoephedrine hydrochloride.
• The other ingredients are: microcrystalline cellulose, corn starch, lactose monohydrate, magnesium stearate, anhydrous colloidal silica, and AquaPolish P coating with the composition: hypromellose, hydroxypropylcellulose, macrogol, medium-chain triglycerides, talc, titanium dioxide (E 171), Allura Red AC (E 129), black iron oxide (E 172), red iron oxide (E 172).

What PSEUDOEPHEDRINE ESPEFA looks like and contents of the pack

PSEUDOEPHEDRINE ESPEFA is a round, biconvex, red coated tablet.
The packaging contains 12 coated tablets.

Marketing authorization holder and manufacturer

Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208
30-133 Kraków
tel. 12 639 27 27
Information for the blind and visually impaired:800-007-777
Date of last revision of the leaflet:17.06.2024